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Physiologically-Based Pharmacokinetic Models for Optimal Drug Dosing in Children

基于生理学的儿童最佳药物剂量的药代动力学模型

基本信息

批准号：
8661919
负责人：
Michael Cohen-Wolkowiez
金额：
$ 62.14万
依托单位：
DUKE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2014
资助国家：
美国
起止时间：
2014-08-01 至 2018-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8661919
关键词：
Accounting Age Caring Characteristics Child Child Development Childhood Clindamycin Clinical Research Clinical Trials Clinical Trials Design Collection Data Development Doctor of Philosophy Dose Drug Prescriptions Drug usage Enrollment Environment Genetic Genetic Information Processing Pathway Goals Individual Infection Investigational New Drug Application Label Legal patent Medical Methodology Modeling Monitor National Institute of Child Health and Human Development Patients Pharmaceutical Preparations Pharmacologic Substance Physiological Processes Physiology Population Principal Investigator Property Protocols documentation Public Health Publishing Recording of previous events Research Research Infrastructure Research Institute Research Personnel Safety Sample Size Sampling Science Staging Staphylococcus aureus Toxic effect Training Treatment Failure Trimethoprim-Sulfamethoxazole Validation base data management design drug development effective therapy experience member model development pharmacodynamic model pharmacokinetic model prospective public health relevance skills tool

项目摘要

DESCRIPTION (provided by applicant): The majority of off-patent drugs prescribed to children lack dosing information specific to this population, which can result in treatment failures and toxicities. Dosing information is lacking because clinical trials involving children pose specific challenges, among the most important of which is the large number of children required to estimate appropriate dosing at every stage of child development. Population physiologically based pharmacokinetic (PBPK) models are mathematical tools that incorporate changes of childhood, along with drug characteristics and genetic variances, to find the most appropriate dose for every pediatric age. By incorporating these factors, PBPK models can reduce the number of children needed for clinical trials. This proposal will systematically develop, and prospectively validate, population PBPK modeling in children.

描述（由申请人提供）：大多数处方给儿童的非专利药物缺乏针对该人群的剂量信息，这可能导致治疗失败和毒性。缺乏剂量信息是因为涉及儿童的临床试验提出了具体的挑战，其中最重要的是需要大量儿童来估计儿童发育每个阶段的适当剂量。基于群体生理学的药代动力学（PBPK）模型是一种数学工具，它结合了儿童时期的变化，沿着药物特征和遗传变异，以找到每个儿科年龄的最合适剂量。通过整合这些因素，PBPK模型可以减少临床试验所需的儿童数量。该提案将系统地开发和前瞻性验证儿童群体PBPK模型。